Investigating the rate of surgical site infection in two methods of continuous and discrete sutures for primary wound closure in gastric and intestinal surgeries: A randomized clinical trial study
Comparison of the rate of surgical site infection in two simple and continuous suture methods for primary wound closure in stomach and intestinal surgeries
Design
Clinical trial, with parallel groups, randomized, on 154 patients. The block randomization method was used for randomization.
Settings and conduct
This study is a randomized clinical trial, which was performed on 154 patients who were referred to the independent educational and medical centers of Qazvin province in 1402, who are candidates for stomach and intestinal surgery according to the surgeon's orders, randomly one of the two methods of suturing ( simple and continuous) is done with three-zero nylon thread
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for stomach and intestinal surgery; Age range 18-80
Non-inclusion criteria: Having diabetes; Immune system diseases; History of gastrointestinal surgery; Pregnancy; Drug abuse; Smoking; Intestinal-to-skin fistula; Anastomosis leakage; Peritonitis during surgery; Abscess and collection during surgery; Hypoproteinemia
Intervention groups
One of the two methods of suturing (simple and continuous) with three-zero nylon thread is performed on the patients randomly. The length of the wound and other characteristics are recorded in the checklist. After surgery, patients are hospitalized for seven days.
Main outcome variables
Scar rate, pain, fever, leukocytosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230826059259N1
Registration date:2023-08-28, 1402/06/06
Registration timing:prospective
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Sara Arsham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
sara_arsham@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the rate of surgical site infection in two methods of continuous and discrete sutures for primary wound closure in gastric and intestinal surgeries: A randomized clinical trial study
Public title
Investigating the rate of surgical site infection in two methods of continuous and discrete sutures for primary wound closure in gastric and intestinal surgeries at the independent educational-therapeutic center Velayat in Qazvin: A randomized clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing gastric and intestinal surgery
Age range 18-80
Exclusion criteria:
Having diabetes
Immune system diseases
History of gastrointestinal surgery
Pregnancy
Smoking, drugs and alcohol
Hypoproteinemia
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation in this study is Balanced Block Randomization. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.QUMS.REC.1402.127
Health conditions studied
1
Description of health condition studied
Infection at the surgical suture site
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
Accumulation of pus under the skin
Timepoint
From the time of completion of surgery to thirty days after that
Method of measurement
Clinical examination by a doctor
2
Description
Active secretions from the wound surface
Timepoint
From the time of completion of surgery to thirty days after that
Method of measurement
Clinical examination by a doctor
3
Description
Leukocytosis (white blood cells less than 4500)
Timepoint
From the time of completion of surgery to seven days after that
Method of measurement
CBC test
4
Description
Pain at the wound site
Timepoint
From the time of completion of surgery to thirty days after that
Method of measurement
McGill pain questionnaire
5
Description
Fever
Timepoint
From the time of completion of surgery to thirty days after that
Method of measurement
Clinical examination by a doctor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Making interrupted suture with three-zero nylon
Category
Treatment - Surgery
2
Description
Intervention group: Making continuous suture with three-zero nylon
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Sara Arsham
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
Clinical_research@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mahidi Mirhashemi
Street address
Mavaddat Alley ,Research and Technology deputy, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sara Arsham
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
sara_arsham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sara Arsham
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Qazvin, Minovar, Independent Medical Education Center Velayat
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Fax
Email
sara_arsham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sara Arsham
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Qazvin, Minovar, Independent Medical Education Center Velayat
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Fax
Email
sara_arsham@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after individuals are de-identified
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of analysis of the delivered data is allowed
From where data/document is obtainable
Refer to Dr. Sara Arsham's email "sara_arsham@yahoo.com"
What processes are involved for a request to access data/document
After publishing the article, the applicant can send a clear request to the author to access the data by sending an email. So, after reviewing the request within 2 weeks, access to data and information is allowed.